Phase 3 Rheumatoid Arthritis Trial, Completed NCT00973479 Sponsor: Centocor, Inc. Condition: Rheumatoid Arthritis
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial enrolled 592 people in total — 197 in the placebo-plus-methotrexate group and 395 in the golimumab-plus-methotrexate group. The study was looking at people with rheumatoid arthritis (a condition causing joint pain and swelling) and was primarily measuring how many participants showed a meaningful improvement in their joint symptoms and overall disease signs by week 14. A number of secondary measures were also tracked, including physical function, disease activity scores, and X-ray evidence of joint damage. The reported data shows that by week 14, around 24.9% of participants in the placebo-plus-methotrexate group met the main improvement target (called an ACR 20 response — meaning at least 20% improvement across several joint and wellbeing measures), compared with 58.5% in the golimumab-plus-methotrexate group. For the secondary measures at week 14, the reported data shows that 40.1% of the placebo group showed a moderate or good improvement on a standard disease activity score (DAS28), compared with 81.3% in the golimumab group. On a physical function questionnaire scored from 0 (no difficulty) to 3 (completely unable), the placebo group's score improved by an average of 0.125 points, while the golimumab group improved by an average of 0.500 points. By week 24, around 13.2% of the placebo group reached an even higher improvement target (ACR 50 — at least 50% improvement), compared with 34.9% in the golimumab group. On an X-ray-based measure of joint damage (scored from 0 to 448, where higher numbers mean more damage), the placebo group showed an average change of +1.09 points from the start, while the golimumab group showed an average change of +0.03 points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 3 Rheumatoid Arthritis Trial, Completed

NCT00973479
Completed Phase 3 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with rheumatoid arthritis (a condition where the immune system attacks the joints) for at least 3 months before the screening visit.
  • You have been taking methotrexate (a common arthritis medication) at a dose of at least 15 mg per week for at least 3 months, and your dose has been stable between 15–25 mg per week for at least 4 weeks before screening.
  • Your rheumatoid arthritis is currently active, meaning you have at least 6 swollen joints and 6 tender joints at both the screening and baseline visits.
  • A blood test at screening shows your C-Reactive Protein (a marker of inflammation in the body) is at a certain elevated level (1.0 mg/dL or higher).
  • You have no history of tuberculosis (TB), either past or active, before the screening visit.

Who may not be able to join:

  • You have another inflammatory condition such as psoriatic arthritis, ankylosing spondylitis, lupus, or Lyme disease.
  • You have taken certain other immune-suppressing or disease-modifying medications (other than methotrexate) in the 4 weeks before the first dose of the study drug — examples include hydroxychloroquine, leflunomide, azathioprine, or cyclosporine (confirm with trial site for the full list).
  • You have received steroid injections into a joint, muscle, or vein in the 4 weeks before the first dose of the study drug.
  • You have a known allergy to golimumab (the study drug) or to human immunoglobulin proteins used in similar medications.
  • You have previously received any anti-TNF therapy, such as infliximab, adalimumab, etanercept, or golimumab, whether as a commercial treatment or as part of another trial.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 14 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Centocor, Inc. Clinical Trial, Centocor, Inc.

Australian sites

, Cairns,
, Maroochydore,
, Melbourne,
, Woodville,
, Woolloongabba,

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Completed
Phase
Phase 3
Sponsor
Centocor, Inc.
Registry
ClinicalTrials.gov
Start date
1 September 2009
Est. completion
1 March 2011

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇨🇴 Colombia 🇭🇺 Hungary 🇱🇹 Lithuania 🇲🇾 Malaysia 🇲🇽 Mexico 🇳🇿 New Zealand 🇵🇱 Poland 🇷🇺 Russia 🇰🇷 South Korea 🇺🇦 Ukraine 🇺🇸 United States

5 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Proportion of Participants With an American College of Rheumatology (ACR) 20 Response at Week 14

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 14 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov